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FDA Approves ACTOplus met(R) XR (pioglitazone HCl and metformin HCl extended-release) Tablets for the Treatment of Type 2 Diabetes
Date:5/13/2009

they have it. Type 2 diabetes is a progressive and chronic condition and requires continued monitoring by a patient and physician, and in addition to diet and exercise, patients may need to take multiple medications at any time in order to help maintain glucose control. In 2007, the world is estimated to have spent at least $232 billion to treat and prevent diabetes and its complications. By 2025, this estimate will exceed $302.5 billion.

Important Safety Information about ACTOplus met(R) (pioglitazone HCl and metformin HCl) and ACTOplus met(R) XR (pioglitazone HCl and extended-release metformin HCl)

ACTOplus met and ACTOplus met XR are not for everyone. Certain patients with heart failure should not start taking ACTOplus met and ACTOplus met XR. ACTOplus met and ACTOplus met XR can cause or worsen congestive heart failure. Talk to your doctor immediately if you experience rapid weight gain, fluid retention (swelling), or shortness of breath.

A small number of people who have taken metformin, a component of ACTOplus met and ACTOplus met XR, have developed a rare, serious condition called lactic acidosis. Lactic acidosis, a buildup of lactic acid in the blood, can be fatal in about half the cases. Because lactic acidosis occurs most frequently in people with kidney problems, ACTOplus met and ACTOplus met XR should not be used in people with kidney disease or in people 80 years of age and older whose kidneys do not work properly. ACTOplus met and ACTOplus met XR should not be taken by people with metabolic acidosis, or with hypersensitivity to
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SOURCE Takeda Pharmaceutical Company Limited
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